Clinical Comparison of Different Flowable Resin Composites
Primary Purpose
Tooth Diseases
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Constic
G-ænial Universal Flo
Tetric N-Flow (self-etch)
Tetric N-Flow (etch&rinse)
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases focused on measuring flowable resin composite, occlusal
Eligibility Criteria
Inclusion Criteria:
- having no medical or behavioral problems preventing then from attending review visits
- absence of previously placed restorations
- having antagonist teeth
Exclusion Criteria:
- poor gingival health
- uncontrolled, rampant caries
- bruxism
- removable partial dentures
- xerostomia
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Constic
G-ænial Universal Flo
Tetric N-Flow (self-etch)
Tetric N-Flow (etch&rinse)
Arm Description
Constic (DMG, Hamburg, Germany)
G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode)
Outcomes
Primary Outcome Measures
Clinical performances of different flowable resin composite
Two year results according to USPHS criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04324008
Brief Title
Clinical Comparison of Different Flowable Resin Composites
Official Title
Clinical Comparison of Different Flowable Resin Composites
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate a self-adhesive flowable resin composite, a flowable resin composite with high viscosity and a conventional flowable resin composite in combination with a universal adhesive using two different application modes. All patients will receive at least 4 occlusal restorations. Cavities will be divided into four groups according to restorative systems used: Constic (a self-adhering flowable composite), G-ænial Universal Flo (a highly filled flowable composite), Tetric N-Flow (self-etch) (a conventional flowable composite), Tetrin N-Flow (etch&rinse).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
flowable resin composite, occlusal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Constic
Arm Type
Experimental
Arm Description
Constic (DMG, Hamburg, Germany)
Arm Title
G-ænial Universal Flo
Arm Type
Experimental
Arm Description
G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode)
Arm Title
Tetric N-Flow (self-etch)
Arm Type
Experimental
Arm Description
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode)
Arm Title
Tetric N-Flow (etch&rinse)
Arm Type
Experimental
Arm Description
Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode)
Intervention Type
Device
Intervention Name(s)
Constic
Intervention Description
Flowable resin composite
Intervention Type
Device
Intervention Name(s)
G-ænial Universal Flo
Intervention Description
Flowable resin composite
Intervention Type
Device
Intervention Name(s)
Tetric N-Flow (self-etch)
Intervention Description
Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)
Intervention Type
Device
Intervention Name(s)
Tetric N-Flow (etch&rinse)
Intervention Description
Tetric N-Flow (Tetric N-Bond Universal, etch&rinse mode)
Primary Outcome Measure Information:
Title
Clinical performances of different flowable resin composite
Description
Two year results according to USPHS criteria
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
having no medical or behavioral problems preventing then from attending review visits
absence of previously placed restorations
having antagonist teeth
Exclusion Criteria:
poor gingival health
uncontrolled, rampant caries
bruxism
removable partial dentures
xerostomia
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Different Flowable Resin Composites
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